MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 14 FLOPPY 205CM; WIRE, GUIDE, CATHETER

Model Number	M001468070
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device discovered that the subject guidewire ptfe (polytetrafluoroethylene) and hydrophilic coating peeling.There were no clinical consequences to the patient reported as a result of this event.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Visual inspection of the subject device revealed that subject guidewire was noted to be kinked/bent at 195.5cm.The guidewire ptfe (polytetrafluoroethylene) was noted to be peeling in multiple areas to 46cm from the proximal end and the hydrophilic coating was noted to be peeling at 38.9cm from the distal tip.Additionally, guidewire distal tip was noted to be irregularly shaped.The guidewire was hydrated, and no anomalies were noted.The guidewire was successfully advanced through a flushed demonstration sl-10 microcatheter.Slight friction was noted as the guidewire approached the distal tip of the microcatheter.The torque device was not returned.An attempt was made to reshape the tip of the guide wire.It reshaped with difficulty.After 15 to 20 minutes, it was noted that the guidewire distal tip was losing shape.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information provided by the customer indicated that the device was confirmed to be in good condition after unpacking and preparation, the device was prepared as per the dfu, the catheter was flushed, and an insertion tool was used to facilitate insertion of the guidewire into the microcatheter.During analysis, the guidewire was noted to be kinked/bent at 195.5cm from the proximal end.The guidewire ptfe (polytetrafluoroethylene) was noted to be peeling in multiple areas to 46cm from the proximal end and the hydrophilic coating was noted to be peeling at 38.9cm from the distal tip.This damage to the coating is consistent with backloading the proximal end of the guidewire into the distal end of the introducer and pulling it through the introducer at an angle.The guidewire distal tip was noted to be irregularly shaped (s-shaped), confirming the reported event.The guidewire od (diameter) was found to be within specifications.During functional testing, the guidewire was advanced through a flushed demonstration sl-10 microcatheter and slight friction was noted as the guidewire approached the distal tip of the microcatheter likely due to the kink.An attempt was made to reshape the tip of the guidewire and it reshaped with some difficulty.After 15 to 20 minutes, it was noted that the guidewire distal tip was losing shape.An assignable cause of handling damage will be assigned to the as reported and as analyzed 'guidewire distal tip irregularly shaped' and 'guidewire distal tip poor shape retention' as well as the as analyzed guidewire kinked/bent', 'guidewire ptfe coating peeling', 'hydrophilic coating peeling' and 'guidewire friction' since these issues are associated with handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.Since the torque device was not returned, the reported torquer issue (impossible to tighten on the guidewire) could not be confirmed.Therefore, an assignable cause of undeterminable will be assigned to the as reported ¿guidewire torque problem'.While the torque device was not returned for investigation and it was not possible to confirm a manufacturing assignable cause, it is possible that the reported complaint may be associated with this issue.Additional analysis from the supplier (bsc) concluded that the s-shape was confirmed during product analysis and the guidewire was found to be within specifications.Even though the returned device was found within product specifications there were commonalities identified related with the sub assembly lots associated with the complaints reported during july and september 2022.Hence, further investigate the event and look at potential improvements to enhance shape retention.

• Brand Name: TRANSEND EX 14 FLOPPY 205CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CS 20101
• Manufacturer (Section G): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CS 20101
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 15891875
• Report Number: 3008853977-2022-00056
• Device Sequence Number: 17447756
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: 08714729326250
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K944677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2023
• Device Model Number: M001468070
• Device Catalogue Number: M001468070
• Device Lot Number: 28396760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown